MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: a 2 cm piece of the catheter tip was noted to be missing when removed from the patient at end of case.Patient did have an x-ray but the missing piece was not located.They are unsure if tip was missing prior to insertion.
Additional Manufacturer Narrative
This report has been identified as b.Braun inc.Internal report number (b)(4).One used catheter was received for evaluation.The sample was visually evaluated and the reported shearing of the catheter was confirmed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformance of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.While no specific conclusion can be drawn, incidents of this nature can occur if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6438866
• Report Number: 2523676-2017-00037
• Device Sequence Number: 16157745
• Product Code: OGE
• UDI-Device Identifier: 04046964177262
• UDI-Public: (01)04046964177262(17)180430(10)0061512426
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 332081
• Device Catalogue Number: 332081
• Device Lot Number: 0061512426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1